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Read the complete FDA clearance document.

FDA 510(k) Clearance

NovaVision™, Inc. obtained FDA clearance in April 2003

The U.S. Food and Drug Administration granted 510(k) clearance to NovaVision Inc.’s Vision Restoration Therapy on April 22, 2003.

Intended Use

NovaVision VRT is intended for the diagnosis and improvement of visual functions in patients with impaired vision that may have resulted from stroke, trauma, inflammation, surgical removal of brain tumors or brain surgery.